POLARIS 2004 CAPNOGRAPH

K040011 · Oridion , Ltd. · CCK · May 13, 2004 · Anesthesiology

Device Facts

• Record ID: K040011
• Device Name: POLARIS 2004 CAPNOGRAPH
• Applicant: Oridion , Ltd.
• Product Code: CCK · Anesthesiology
• Decision Date: May 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Polaris 2004 Capnograph is intended for the continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath of neonatal, pediatric and adult patients wherever these measurements are required by attending medical personnel.

Device Story

The Polaris 2004 Capnograph is a carbon dioxide gas analyzer used by medical personnel to monitor patient ventilatory status. It utilizes infrared radiation to measure CO2 concentration in gas mixtures; it derives respiration rate from these CO2 measurements. The device features an internal MiniMediCO2 module and an aluminum manifold for gas sampling, replacing previous plastic tubing and connectors to improve reliability and reduce size. It operates with the Filterline gas sampling accessory, which eliminates the need for a water trap. The device provides continuous, non-invasive monitoring, displaying CO2 levels in mmHg, Vol %, or kPa. By providing real-time data on respiratory function, it assists clinicians in assessing patient ventilation, potentially benefiting patients by enabling timely intervention in clinical settings.

Clinical Evidence

Bench testing only. The device complies with the EN864 performance standard for capnographs.

Technological Characteristics

Carbon dioxide gas analyzer using infrared radiation sensing. Components include an Oridion MiniMediCO2 module and an aluminum manifold for pneumatic gas sampling. Dimensions and power requirements are reduced compared to the predicate. Complies with EN864 performance standards.

Indications for Use

Indicated for continuous, non-invasive monitoring of respiration rate and CO2 concentration in expired/inspired breath for neonatal, pediatric, and adult patients.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Polaris Capnograph (K950388)

Reference Devices

• Oridion Microcap (K981114)
• Filterline (K980324)
• K964239
• K980327
• K011536
• K011050
• K023400

Submission Summary (Full Text)

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K040011

### MAY 1 3 2004

## 510(k) Summary of Safety and Effectiveness Information

#### PRODUCT NAME

Proprietary: Polaris 2004 Carbon Dioxide Gas Analyzer Common:

#### ESTABLISHMENT REGISTRATION NUMBER

Establishment Registration Number: 8044004 ESTABLISHMENT ADDRESS: Oridion Medical 1987 Ltd.

POB 45025 91450 Jerusalem Israel

#### CONTACT PERSON:

Sanford Brown, Regulatory Affairs Director Oridion Medical 1987 Ltd. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel Telephone: [phone] FAX: [phone] Email: [e-mail]

### DEVICE LISTING FDA FORM 2892:

B051971

#### DEVICE DESCRIPTION

The Oridion Polaris Capnograph (the device being modified-K950388) is a device that measures end tidal CO2 (EtCO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR). The capnograph module of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status.

#### Substantial Equivalence Information

The modified device, the Polaris 2004 Capnograph, incorporates all the functions of the Polaris monitor. It is equivalent, in terms of indications for use and technological characteristics to the Polaris Capnograph K950388.

#### CLASSIFICATION Class II 73CCK

The Polaris 2004 Capnograph has been classified as follows:

21 CFR, Section 868.1400, carbon dioxide analyzer. The Capnograph device measures the concentration of carbon dioxide in a gas mixture by the use of infrared radiation as described in 868.1400. Its classification is Class II (performance standards). Since no

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performance standards have been issued, it will be regulated by the Special Controls penormanoo bandards neets the standard EN864 for capnographs that has been accepted by the FDA.

## Differences Between The Polaris Capnograph and the modified Polaris 2004.

The cleared Polaris Capnograph device uses the Oridion generic CO2 module and the modified Polaris 2004 device uses the Oridion MiniMediCO2 module The Oridion MiniMediCO2 CO2 module is essentially equivalent to the CO2 module used in the Oridion Microcap (K981114). The MiniMediCO2 module takes advantage of the current availability of smaller mechanical, electrical and electronic components with lower availables ower requirements. The basic design, intended use and indication of the Polaris 2004 remain the same and the design modifications have not altered the f oldno 2001 Fornalif the chnology, materials or manufacturing processes of the Polaris. The gas sampling line Fitterline K980324, specified for use with this modified device, eliminates the need for a water trap. The changes pose no new issues of safety or efficacy.

#### Flow And Gas Sampling System

The Polaris and the modified device (Polaris 2004) use the identical flow and gas sampling system and pneumatic system. The Polaris uses plastic tubing and plastic connectors to construct the pneumatic system. The modified device uses an aluminum oonnifold to replace all the plastic tubing and connectors thereby reducing the size and cost and improving the reliability. The pump and solenoid used in the current device have been replaced by smaller more efficient and reliable components. The water trap used on the current device has been removed since the Oridion gas sample Filterline (K980324) accessory eliminates the need for a water trap. The removal of the water trap on Oridion capnographs has been universal (K964239, K981114, K980324, K023400) since the introduction of the Filterline CO2 gas sampling lines (K980324, K980327, K011536, K011050).

#### Indications for Use:

The Polaris 2004 Capnograph is intended for the continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath of neonatal, pediatric and adult patients wherever these measurements are required by attending medical personnel.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of an eagle with three overlapping wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 3 2004

Oridion Medical 1987 Limited C/O Mr. Sandy Brown Regulatory Affairs Director Oridion Capnography, Incorporated P.O. Box 45025 91450 Jerusalem, Israel

Re: K040011

Trade/Device Name: Polaris 2004 Capnograph Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: March 11, 2004 Received: March 16, 2004

Dear Mr Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into cither class II (Spccial Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Brown

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements modified in 21 may Federal statutes and regulations administered by other Federal agencies. of the Act of all ] Pouchal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice une noting (2) eart forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) Prins letter notification. The FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you deate speed to the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj South Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Suarez

A Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040011

Device Name: Polaris 2004 Capnograph

Indications for Use:

The Polaris 2004 Capnograph is intended for the continuous, non-invasive The Folans 2004 Oaphograph is internation rate and carbon dioxide concentration of measurement and montoning of roopnation railance and adult patients wherever these the oxplied and required by attending medical personnel.

Prescription Use __________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ceeen Sulum

Infection i 510(k) Numbe

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